Clinical TrialMay 11, 2026, 04:03 PM
aTyr Pharma to advance efzofitimod to new Phase 3 study in pulmonary sarcoidosis
AI Summary
aTyr Pharma announced a clear path forward for its lead therapeutic candidate, efzofitimod, in pulmonary sarcoidosis, following feedback from a Type C meeting with the FDA. The company plans to submit an Investigational New Drug (IND) application in June 2026 for a new Phase 3 study. This study will focus on patients with chronic, symptomatic pulmonary sarcoidosis with restrictive lung disease, utilizing FVC as the primary endpoint and KSQ-Lung as a key secondary endpoint, with an increased dosing frequency.
Key Highlights
- aTyr Pharma plans a new Phase 3 study for efzofitimod in pulmonary sarcoidosis.
- Investigational New Drug (IND) application for the study to be submitted in June 2026.
- The new Phase 3 study will use Forced Vital Capacity (FVC) as the primary endpoint.
- King’s Sarcoidosis Questionnaire (KSQ)-Lung score will be the key secondary endpoint.
- Dosing frequency for 5.0 mg/kg efzofitimod will increase to once every three weeks.
- The study aims to enroll up to approximately 372 patients with moderate to severe pulmonary sarcoidosis.
- A conference call and webcast are scheduled for May 11 at 4:30pm ET to discuss the update.
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